Stereotactic device for implantation of permanent implants into a rodent brain

ABSTRACT

Stereotactic systems and implantation methods that can be designed for use with a specific species and further customized for use with an individual within the species are provided. The stereotactic system can include an implant jig that can model a tissue or organ in which a target tissue area is located. A neurocap can be coupled to the implant jig for pre-planning and pre-placement of implants. A stencil can be used to determine the location for placement of the neurocap on the individual, so that the implants can be precisely targeted at the desired location. Pre-surgical information and data can be obtained from an individual and used to customize components of a stereotactic system, which can improve accuracy of implant placement.

BACKGROUND

Stereotactic devices are used for accurate surgical positioning ofprobes, electrodes, catheters, and other intra-body devices, such as inthe brain, spine, lung, and liver. Stereotactic surgical procedures toplace these types of devices within body or tissue can require accuracyto within millimeters or even micrometers. Such accuracy can depend uponthe stereotactic devices used to guide the intra-body devices tospecific points in the body.

Placement of intracranial devices requires particular accuracy. Thereare several types of stereotactic devices used for guiding and placingintracranial devices. Some of these devices fix the position of the headand utilize a Cartesian coordinate system to relate the known featureson skull to an external grid. Others use a frame system that attaches tothe skull and utilize a polar coordinate system to relate features onthe skull to the known locations of other features. One specific systemrequires a burr-hole be drilled into the skull and the stereotacticdevice is affixed within the burr-hole. The stereotactic device is thenused to guide intracranial devices into the brain through the burr-hole.

Stereotactic devices utilized for implantation of devices in humans canbe quite different than those used for implantation into animals. Evenstereotactic devices used for animal implantations can be different fordifferent animal species. The differences in anatomy, size, orientationof features, and points of attachment necessitate different types ofstereotactic devices for different species.

Another issue is intracranial devices that are permanently orsemi-permanently emplaced for long term treatment, therapies, orresearch. Such intracranial devices often have externally exposed ends,protruding outside the body. The exposed ends should be supported toensure that the intracranial placed devices remain in position. Thosethat provide a direct conduit into the body need to be covered to ensurethat undesirable materials are not introduced into the brain.Intracranial devices implanted in animals can be particularlyproblematic, since the animal will often actively attempt to remove ordisplace the exposed ends.

BRIEF SUMMARY

Embodiments of the subject invention address the problems of accuratelyplacing and supporting intracranial devices on subjects (e.g., subjectof different species) by providing an external stereotactic system thatcan be partly customized to the skull anatomy of a specific subject(e.g., a specific species). Components of the stereotactic system allowintracranial implant devices to be pre-arranged to the appropriatedirection and depth before implantation. Advantageously, components ofthe stereotactic system can be attached directly to the skull to supportand contain the exposed ends of the intracranial devices. A stereotacticsystem customized for a specific species can be used on individualswithin the species with higher accuracy and more comfortable and securepermanent or semi-permanent placement on the skull.

Prior to a neurosurgical procedure, it is not uncommon to obtain a3-dimensional (3D) image of the brain, skull, and other structures, sothat placement of intracranial devices can be pre-planned. Likewise,such 3-D images can also be used to customize components of thestereotactic system and pre-plan the placement of intracranial devices,using components of the stereotactic system of the subject invention.There are a variety of methods and techniques available for obtaining3-D images and the invention is not limited to the method or techniqueused. The stereotactic system can include a surgical stencil with one ormore surfaces customized to match an operating area of the skull anatomyof a specific species. The scanned or imaged operating area of the skullcan be used to customize edges and surfaces of components of astereotactic system of the subject invention.

The surgical stencil can be matched to the operating area of the skullthrough which the intracranial devices will be inserted into the brain.The surgical stencil can also have openings that match the locationwhere an intracranial device will enter the brain. The customizedsurgical stencil can be placed directly against the subject's skull,using known landmarks. The bregma and/or lambda landmarks can be used,and the surgical stencil can be placed relative to the location of theselandmarks. The surgical stencil can include additional holes throughwhich the surgical stencil can be secured to the skull, such as, forexample, with temporary screws. Once the customized surgical stencil ispositioned and temporarily secured to the skull, the marking holes canbe used to make indicator marks directly on the skull for later use indrilling one or more burr holes in the proper location into the skull.

In many embodiments, a stereotactic system can also include a neurocapand an implant jig, which can be used together to pre-plan, implant, andsecure the placement of intracranial implants. The implant jig canprovide a framework structure on which the neurocap can be placed. Theimplant jig can also be customized to have a space therein that modelsthe length, width, and volume of the brain of a specific species. Theneurocap can be placed on the implant jig in a precise position thatmimics how the neurocap will be eventually fixed on the skull. A marginplate on the implant jig can also hold the neurocap above the space inthe implant jig. Thus, placement of the neurocap on the implant jig canmimic the location of the neurocap as it would be when secured to theskull and the location relative to the brain when in that location.

The neurocap and implant jig, when combined, can provide a guide intowhich various intracranial devices can be inserted. The neurocap canprovide a structure to which intracranial implants can be secured, andthe implant jig, with the space mimicking the brain, can be used todetermine the depth of intracranial implants. The implants can beinserted through the neurocap and into the space of the implant jig,which can mimic insertion of intracranial implants into the brain of thespecific species.

One or more sleeves can be incorporated into the implant jig and/or theneurocap to assist with placement of intracranial implants through theneurocap and/or the implant jig. The location of the sleeves can bedictated by where the intracranial implants are to be placed in thebrain. Thus, the location of the sleeves can also be customized for aparticular procedure to be performed on the specific species.Furthermore, one or more of the sleeves in a neurocap can align with thesleeves in an implant jig.

After the intracranial implants are in place, the ends exposed outsidethe skull can be secured within the neurocap. The neurocap can beremoved from the implant jig, which can expose the proximal ends of theintracranial implants or the ends of the implants that will be insertedinto the brain. The neurocap implant can be positioned above the skulland oriented so that the proximal ends of the intracranial implants arealigned with the burr holes created using the surgical stencil. Usingthe holes formed at the bregma and lambda landmarks using the surgicalstencil, the neurocap can be pushed directly downward on the skull,which will align it in the same position as the surgical stencil. Thiscan also position the proximal ends of the intracranial implants in thesame exact position in the subject's brain as they were in the spacemodeling the subject's brain. The neurocap can be secured to the skullto ensure that the intracranial implants remain in place.

In an embodiment, the stereotactic system can include a protective coverthat can be placed over the neurocap. Once the neurocap has beenemplaced and secured to the skull, the protective cover can be placedover the neurocap and removed as necessary to utilize the intracranialimplant exposed ends.

Advantageously, the stereotactic system of embodiments of the subjectinvention can have interface surfaces that are a positive or negativerepresentation of an area on the skull surface of an individual subjectof a specific species. A negative interface surface is one that has oneor more impressions, indentations, or hollows that are the reverseimpression of an operating area. A positive interface surface is onethat has one or more raised or 3D characteristics similar to oridentical to those of an operating area. A positive interface surface ofan operating area can interdigitate with or interfit with a negativeinterface surface of the same operating area. Thus, positive andnegative interface surfaces can be fit together or seated against eachother to provide more accuracy in the pre-placement and eventualimplantation of intracranial implants. For example, a proximal endsurface of the neurocap can be formed as a negative interface surface tocompliment or couple with an operating area of an individual skull onwhich it will be affixed. Conversely, a distal end surface of the marginplate on an implant jig can be formed as a positive interface surface ofthe same area of the skull on which the neurocap will be affixed.Placement of the neurocap interface surface against the implant jiginterface surface allows these two surfaces to be at least partially tosubstantially interfit or coupled together in close proximity. Thisincreased proximity can increase the accuracy in placing theintracranial implants.

In many embodiments, a stereotactic system can be customized or adaptedfor use with general characteristics for a specific species. Componentscan also be further customized with interfacing surfaces that model theactual surface area of an individual of a specific species. Componentsalso allow configuration and placement of intracranial implants to bedetermined prior to actual implantation within a subject. Theinterfacing of certain surfaces on components of the stereotactic systemprovides greater accuracy in implant placement for a specific species.

BRIEF DESCRIPTION OF THE DRAWINGS

In order that a more precise understanding of the above recitedinvention can be obtained, a more particular description of theinvention briefly described above will be rendered by reference tospecific embodiments thereof that are illustrated in the appendeddrawings. The drawings presented herein may not be drawn to scale andany reference to dimensions in the drawings or the following descriptionis specific to the embodiments disclosed. Any variations of thesedimensions that will allow the subject invention to function for itsintended purpose are considered to be within the scope of the subjectinvention. Thus, understanding that these drawings depict only typicalembodiments of the invention and are not therefore to be considered aslimiting in scope, the invention will be described and explained withadditional specificity and detail through the use of the accompanyingdrawings.

FIG. 1 is an illustration of a stereotactic system, without the stencil,according to an embodiment of the subject invention.

FIG. 2 is an illustration of an exploded view of a stereotactic system,without the stencil, according to an embodiment of the subjectinvention.

FIG. 3 is a photograph showing the disassembled components for astereotactic system, according to an embodiment of the subjectinvention.

FIG. 4 is an illustration of an implant jig, according to an embodimentof the subject invention.

FIG. 5 is a distal plan view of the implant jig shown in FIG. 4.

FIG. 6 is a distal end side perspective view of a neurocap, according toan embodiment of the subject invention. Also shown is the neurocapcontacting an operating area.

FIG. 7 is a distal end plan view of the neurocap shown in FIG. 6.

FIG. 8 is a distal end perspective view of a stencil, according to anembodiment of the subject invention. Also shown is the stencilcontacting an operating area.

FIG. 9 is a distal end plan view of the stencil shown in FIG. 8.

FIG. 10 is a side perspective view of a protective cap, according to anembodiment of the subject invention.

FIG. 11 is a distal end plan view of the protective cap shown in FIG.10.

FIG. 12 is a photograph of an individual of a specific species on whicha Neurocap according to an embodiment of the subject invention, with aprotective cap thereon, has been attached to the skull.

FIG. 13 is a distal side perspective view of a stereotactic system,according to an embodiment of the subject invention.

FIG. 14 is a distal side perspective view of a neurocap, according to anembodiment of the subject invention.

FIG. 15 is a distal side perspective view of an implant jig, accordingto an embodiment of the subject invention.

DETAILED DESCRIPTION

Embodiments of the subject invention pertain to stereotactic systemsuseful for implanting and securing intracranial or other types ofimplants. More specifically, stereotactic systems with components thatcan be customized for implanting and securing intracranial implants intothe brain of a specific species are provided. The components of astereotactic system can also have customized interfaces for increasedaccuracy in implant placement.

The following description will disclose that embodiments of the subjectinvention are particularly useful in the field of neurosurgicaltechniques, in particular the implantation of intracranial devices.However, embodiments of the subject invention are not limited to onlyneurosurgical applications or only to the implantation of intracranialdevices. A person with skill in the art will be able to recognizenumerous other uses that would be applicable to the devices and methodsof the subject invention. Thus, while the subject application describes,and many of the terms herein relate to, a use for implantation ofintracranial devices through the skull of a subject, other uses andmodifications apparent to a person with skill in the art and havingbenefit of the subject disclosure are contemplated to be within thescope of the present invention.

In the description that follows, a number of terms are used in relationto the subject invention. In order to provide a clear and consistentunderstanding of the specification and claims, including the scope to begiven such terms, the following definitions are provided.

The terms “subject” and “specific species”, as used herein, describes ananimal, including mammals, to which the devices and methods of thepresent invention can be applied and that can benefit from suchapplication. This can include mammalian species such as, but not limitedto, apes, chimpanzees, orangutans, humans, monkeys; domesticated animals(e.g., pets) such as dogs, cats, guinea pigs, hamsters, Vietnamesepot-bellied pigs, rabbits, and ferrets; domesticated farm animals suchas cows, buffalo, bison, horses, donkey, swine, sheep, and goats; exoticanimals typically found in zoos, such as bear, lions, tigers, panthers,elephants, hippopotamus, rhinoceros, giraffes, antelopes, sloth,gazelles, zebras, wildebeests, prairie dogs, koala bears, kangaroo,opossums, raccoons, pandas, hyena, seals, sea lions, elephant seals,otters, porpoises, dolphins, and whales. It can also include patientsthat range in age from neonates to elderly.

The terms “intracranial implant” or “implant,” as used herein, aremerely for literary convenience. These terms can encompass any tool,mechanism, or device that can be permanently or temporarily inserted,implanted, installed, or otherwise introduced into or onto a subject inneed of such treatment.

Also, as used herein, and unless otherwise specifically stated, theterms “operable communication,” “operable connection,” “operablyconnected,” “cooperatively engaged” and grammatical variations thereofmean that the particular elements are connected in such a way that theycooperate to achieve their intended function or functions. The“connection” or “engagement” may be direct, or indirect, physical orremote.

It is to be understood that the figures and descriptions of embodimentsof the present invention have been simplified to illustrate the elementsthat are relevant for a clear understanding of the invention, whileeliminating, for purposes of clarity, other elements that may be wellknown. Those of ordinary skill in the art will recognize that otherelements may be desirable and/or required in order to implement thepresent invention. However, because such elements are well known in theart, and because they do not facilitate a better understanding of thepresent invention, a detailed discussion of such elements is notprovided herein.

Reference is made throughout the application to the “proximal end” orthe “proximal side” and “distal end” or the “distal side.” As usedherein, the proximal end or proximal side is that end nearest to asubject or, for certain components described herein, the end directedtowards a surface on which the component sits during use. For example,the surface of a neurocap that contacts the skull of a subject is theproximal end, as is the surface of an implant jig that sits closest to asurface during use. Conversely, the distal end or distal side isfurthest from the proximal end or is that end directed away from asubject or a surface.

Reference will be made to the attached figures on which the samereference numerals are used throughout to indicate the same or similarcomponents. With reference to the attached figures, which show certainembodiments of the subject invention, it can be seen in FIG. 1 that inan embodiment, a stereotactic system 50 can include an implant jig 100,a neurocap 200 capable of being fitted onto or seated against theimplant jig. A further embodiment includes a surgical stencil 300 thatcan be used to create marks on the skull for later use in placement ofthe neurocap. There can also be a protective cap 400 that operablyconnects to the neurocap. Each of these general components can have oneor more sub-components and features, which will be discussed in detailbelow.

FIGS. 1 and 2 illustrate the interaction of certain components of thestereotactic system 50 and also demonstrate how surfaces of thecomponents can interfit or be coupled. As illustrated in FIG. 2, therecan be, in an embodiment, an implant jig 100 on which a neurocap 200 isconfigured to fit against, couple with, or seat against. When combined,these two components can be used as a guide 75 for pre-configuring,pre-planning and/or pre-placement of implants 15, prior to theirimplantation in a subject. Thus, a surgical implant procedure can beplanned out prior to actual implementation, by utilizing the guide 75.As discussed above, the neurocap and implant jig can be at leastpartially tailored or customized for a specific species. For example,the volume 107 of an implant jig can model the tissue or organ of aspecific species in which a target tissue area is located and the firstinterface surface 120 and the second interface surface 220 can each beeither at least partially positively or negatively modeled after anoperating area of an individual subject on which the neurocap will beattached. Thus, the guide provided by coupling of these components canbe generally customized for a specific species and can be further moreparticularly customized for an individual subject of the specificspecies.

During manufacture of the components of a stereotactic system 50,information regarding the location of a target tissue area in a subjectcan be used to further customize the location of ports 250 within theguide, for directing implants into the organ or tissue where the targettissue area is located. For example, medical scans, images, radiographs,and other physiological data and information can be used to determinewhere ports should be located on a guide, to ensure that the implantsare accurately directed towards the target tissue area.

Typically, intracranial implants are positioned directly into braintissue after first reviewing and analyzing one or more images of thetissue. The image can be a 2- or 3-dimensional image on which distancesand relative positions can be determined. The depth, direction, andother data regarding the placement of the implant can be determined byreviewing the image prior to the implantation procedure. The implant jigaccording to embodiments of the subject invention can model all or someportion of the brain volume of the specific species. Initially insertingimplants, such as, for example, intracranial implants, into the implantjig, allows the depth, direction, and other factors to be pre-determinedand, if necessary, corrected before the actual implantation into asubject.

In an embodiment, an implant jig 100 has a support plate 105 at theproximal end 5. The support plate can provide a base to which otherelements of the implant jig can be attached. FIG. 4 illustrates anon-limiting embodiment of a support plate. A support plate can have acircumferential shape similar to that of other elements of the implantjig. The support plate can also have other circumferential shapes andsizes.

The implant jig can be configured to encompass a volume 107 that modelsthe brain volume, or some part thereof, in which the implants willeventually be inserted to reach a target tissue area 25. By way ofnon-limiting example, the implant jig can be configured to generallymodel the volume of the brain of a specific species. FIGS. 4, 5, and 15illustrate embodiments of an implant jig having a volume 107 that modelsthe rat brain. In an embodiment, attached to the support plate 105 therecan be at least two posts 110 extending upwards from the support plateand towards the distal end 10. The posts on the support plate canestablish a circumferential boundary for the volume 107 being modeled.In a particular embodiment, at least four posts are attached to thesupport plate, where there is at least one at or near the corners of thesupport plate. FIGS. 13 and 15 illustrate an example of this embodiment.In a further particular embodiment, the posts can have a curvilinearshape that more accurately defines a circumferential boundary for thevolume being modeled. FIGS. 3, 4, and 5 illustrate an example of thiswhere the posts have a curvature along their length that defines orapproximately defines the circumferential boundary of the volume. FIGS.13, 14, and 15 illustrate an alternative embodiment where the posts on asupport plate to not necessarily define a circumferential boundary.

Embodiments of the subject invention can be useful with implants thattraverse a margin or some surface of the body in order to acquire accessto a target tissue area 25. For example, catheters, probes, electrodes,needles, and other types of elongated implants can be inserted throughthe skull to reach a target tissue area 25 in the brain. Embodiments ofthe subject invention can establish an uppermost boundary of the volume107 that corresponds to that of an operating area on the skull. Asmentioned above and explained in more detail below, a neurocap can beused with the implant jig to pre-position implants in the neurocap forlater implantation into a subject. Modeling the operating area of theskull on which a neurocap can be attached can improve the accuracy ofimplant placement in both the neurocap and later in the brain.

In an embodiment, one or more margin plates 115 can be operablyconnected to one or more of the posts 110, as shown, for example, inFIGS. 3, 4, 5, and 15. A margin plate can be operably connected to atleast one post in a location that would form a volume 107 under theproximal side 5 of the margin plate, where the volume models, orgenerally models, that of the brain of a specific species. FIG. 3 showsa non-limiting example of two margin plates 115 each operably connectedto two of four posts 110 attached to the support plate, where the volume107 formed beneath the proximal side 5 of the margin plate 115 modelsthat of the brain of a rat. In other words, a margin plate can representthe layer, surface, or other covering that an implant would pass throughto reach an underlying tissue or organ. For example, a margin plate canmodel a portion of the skull of a specific species through whichimplants will be inserted.

One or more surfaces of a margin plate 115 can beneficially also modelthe shape, configuration, thickness, contours, and/or other surfacedetails 23 of an operating area 20 corresponding to that of a subject ofa specific species. This can make pre-positioning of the implants moreaccurate, as it can allow for adjustments due to individualphysiological features. In an embodiment, the margin plate has a firstinterface surface 120 at the distal side 10. In an embodiment, the firstinterface surface can have a smooth or uniform appearance, such thatthere is minimal or no detail, but that has contours that generallymodel the skull surface. In an alternative embodiment, there can be atleast one feature, contour, landmark, or other detail modeled after thatof an outer layer, exterior, edge, margin, or other portion of anoperating area 20. For example, the first interface surface 120 can haveone or more features that are a positive model of those of an operatingarea on the skull of a specific species through which implants will beinserted. FIG. 4 illustrates an example of a first interface surface onan implant jig with features that are a generally positively model thoseof an actual operating area. FIG. 15 shows an example of a firstinterface surface with features that more accurately positively modelthose that would appear on an actual tissue or organ, here the surfaceof a skull.

One or more images of a tissue are usually acquired before placingimplants. The images can be used to pre-determine the location, depth,angle, and other factors for placement of implants. An implant jig 100can be utilized in conjunction with such images to determine theplacement of implants in a tissue. In an embodiment, the implant jig hasindicators that can be used to assist with determining the placement ofthe implants. As will be discussed below, a neurocap can be utilizedwith the implant jig to secure implants in the correct positions forlater insertion into a tissue. The amount of detail incorporated intothe first interface surface 120 can depend upon a variety of factors,such as, for example, the method or technique employed to manufacturethe margin plate, the method or technique by which the surface detailsare acquired, the level of accuracy necessary for the implant procedure,and other factors known to those with skill in the art.

In a further embodiment, the margin plate has at the proximal side 5 aninterior surface 125. The location of the interior surface, with regardto the attachment of the margin plate 115 to the posts 110, canestablish the volume 107 modeled by the implant jig 100. As with theinterface surface 120 on the distal side 10, the detail of the interiorsurface 125 can assist in more accurate placement of implants, as it canallow for adjustments based on natural physiological features. In anembodiment, the interior surface is smooth or has minimal details. FIG.4 illustrates an example where the interior surface has smooth surfaceswith some general curvature that models an area of a skull. FIG. 15illustrates an example where the interior surface has pronouncedcurvature and contours that more accurately model an area of a skull.

The implant jig 100 can model the surface and underlying tissue in whichimplants will be inserted. As mentioned above, a neurocap 200 can becoupled or seated against the first interface surface of a margin plate115 of an implant jig to assist with pre-placement of implants into theneurocap. Thus, a margin plate that provides a sufficiently accuraterepresentation of the skull area over which the neurocap will beattached can be beneficial in placement of implants. In an embodiment,the edge 130 of a margin plate on an implant jig can also be a model ofthe circumference of the operating area 20 against which a neurocap willbe attached. FIGS. 1, 2, and 13 illustrate an example of a margin platehaving an edge 130 that is generally similar to the circumference of theoperating area 20 and a neurocap 200 placed against the margin plate andcoupled with an implant jig. FIGS. 5 and 15 illustrate examples of amargin plate 115 with edges 130 that model the circumference of theoperating area 20.

Furthermore, implants can be inserted through the neurocap and into thevolume 107 of the implant jig. This can require exerting pressureagainst a margin plate, which can distort the margin plate and affectaccuracy of the implant placement. In a further embodiment, the implantjig includes stanchions 160 that rise from the support plate 105 instrategic locations to contact the proximal end 5 of a neurocap. Thestanchions can support the neurocap and inhibit distortion of the marginplates during placement of implants therein. Examples of stanchions canbe seen in FIGS. 3, 4, 5, and 13.

The neurocap 200 component of the stereotactic system 50 can be utilizedfor placing implants 15 into the target tissue area 25 through theoperating area 20. The neurocap can be attached to an area of the bodythrough which the implants will be inserted, such as, for example, theexterior of skull for accessing brain tissue. The neurocap can bepre-configured to receive implants at specific locations. Thesepre-configured locations can be made to correspond to the target tissuearea 25 in a brain where the implant will be directed. By way ofnon-limiting example, a neurocap can be affixed to the skull over anoperating area 20. The implants 15 pre-positioned within the neurocapcan then be pushed or otherwise moved through the neurocap, through theoperating area and into the brain until the implant or some part thereofreaches the target tissue area 25. The distance by which the implants 15are pushed through a neurocap can be determined in advance by utilizingan implant jig 100, described above.

In an embodiment, a neurocap 200 has an interface plate 210 that can bepositioned against the operating area 20 and attached, permanently orremovably, to secure the position of an implant 15. FIG. 6 illustrates anon-limiting example. Prior to being attached to the operating area 20,the interface plate 210 can be coupled to the one or more margin plates115 on an implant jig 100, for pre-placement of implants in theneurocap. In an embodiment, the interface plate has at least one secondinterface surface 220 on the proximal side 5 that contacts the at leastone first interface surface 120 on the distal side 10 of a margin plate.As mentioned above, it can be beneficial for the first interface surfaceto accurately couple and align with the second interface surface toensure accuracy in placement of implants in the neurocap and later to atarget tissue area 25. In an embodiment, the second interface is anegative model of the operating area, which can allow the secondinterface surface to be interfit with the first interface surface andinterfit with the operating area when the neurocap is attached.

To assist with the placement of the interface plate 200 against one ormore margin plates 100, an implant jig 100 can have alignment structures150 thereon. In an embodiment, an implant jig can have alignment poststhat extend above a margin plate, so that they are distal to the firstinterface surface. The alignment posts can, though are not required to,correspond to the location of the posts 110, such as shown, for example,in FIGS. 13 and 15. In a further embodiment, the interface plate 200 hasone or more alignment holes 225 that fit over the support posts of animplant jig 100. FIG. 13 illustrates one example of alignment holes onalignment posts. In an alternative embodiment, one or more alignmentposts can be positioned or configured so that a margin plate can befittingly positioned between them with minimal tolerance for accuratealignment with a margin plate. FIGS. 1 and 2 illustrate an example ofalignment posts configured or shaped to fit against or conform to anoutside edge 230 of an interface plate 200. With this embodiment, thealignment posts can correspond to the location of the support posts, butthis is not required and the alignment posts can arise from anywhere ona margin plate or the support plate.

Once the interface plate 200 is aligned with the one or more marginplates, the first interface surface 120 can contact the second interfacesurface 220. As mentioned above, the contact between these two surfacescan model the contact that the interface plate will make with theoperating area 20. Thus, the accuracy with which the first interfacesurface 120 and the second interface surface 220 make contact can affectthe accuracy with which implants 15 positioned on the neurocap 200 willreach the target tissue area 25. The characteristics of a firstinterface surface have been discussed above and are reasserted here withregard to a second interface surface. In a particular embodiment, thesecond interface surface has contours, structures, or other details thatallow it to sit or couple securely with a margin plate, but do not,necessarily, model the surface details of an operating area. FIGS. 2, 3,and 6 illustrate an embodiment where the second interface surface hascomplementary details 222 that can interdigitate or interfit withphysiological details 23 of the operating area 20. In another particularembodiment, the second interface surface has contours that more closelymodel the surface details 23 of an operating area, so that the first andsecond interface surfaces can coincide more fully and/or be accuratelycoupled. FIGS. 13 and 14 illustrate an example of this, where the firstand second interface surfaces have contours and features that moreclosely fit together or coincide with each other. The contours of thesecond interface surface can also model natural details of an operatingarea, so that when the neurocap is placed against an operating area thesecond interface surface will coincide with the natural details 23 ofthe operating area.

The attachment of a neurocap 200 to an operating area can beaccomplished by a variety of techniques known in the art. For example,screws, plugs, pins, various adhesives, other devices or materials,and/or combinations thereof can be used. In an embodiment, the neurocapis both screwed onto the target area of the skull and an adhesive isused. In a further embodiment, a neurocap has one or more bores 227 forreceiving a screw or other connector. In still a further embodiment, theinterface plate 210 has one or more cutouts 229 therein that allow anadhesive to pass through to secure the interface plate to an operatingarea.

In a further embodiment, a neurocap has at least one port 250 throughwhich an implant can be inserted. The at least one port can pass throughthe interface plate and lead into the volume 107 of an implant jig 100,such that the appropriate depth can be determined for the implant toreach the target tissue area 20. Utilizing the volume 107 as a model, animplant can be inserted to the correct depth and angle to reach thetarget tissue area 25. For example, if the volume is a model for thebrain of a rat, the implant can be inserted into the volume to a pointthat coincides with that in a living rat. The depth, angle, and otherinformation about the implant can then be marked, measured, or otherwiserecorded and then the implant removed from the volume and/or theneurocap. The port can also have a friction fit with the implant or beotherwise securable within the port, allowing the implant to remain inthe port after being removed from the implant jig volume. When theneurocap is affixed to the operating area, the implants can then bepushed or moved to the pre-measured or pre-recorded depth, which shouldplace the proximal end of the implant in or sufficiently near the targettissue area.

Implants 15 that pass through the neurocap and to the target tissue area25 can have exposed ends 17 that protrude from the operating area.Advantageously, the neurocap can be used to protect the exposed endsfrom undesirable contact and can also secure the position of the exposedends, so that the implant is not moved from the target tissue area inthe body. In an embodiment, the exposed ends are secured to theinterface plate 210. In a further embodiment, the exposed ends aresecured within the ports 250 in the interface plate. Any of variousmethods and devices can be used to secure the exposed ends in the ports,including, but not limited to, connectors, adhesives, adhesive tapes, orother apparatuses known in the art. FIG. 15 illustrates an example of animplant 15 secured to a port 250 in an interface plate 210.

A port 25 can provide an opening in an interface plate for access to theoperating area. Implants can be passed through the ports to reach thetarget tissue area through the operating area. In an embodiment, the atleast one port is surrounded, entirely or partially, by a sleeve 260though which an implant can pass. A sleeve can assist with aiming theimplant through a port and into the body, so that it maintains thecorrect angle to reach a target tissue area 25. Thus, a sleeve can bedirected at any angle that allows an implant to pass through a port andreach a target tissue area. FIGS. 2, 6, and 7 illustrate non-limitingexamples of sleeves surrounding a port.

Customization of a guide 75 can require locating a sleeve 260 in aneurocap coinciding with the location of a stanchion 160 in an implantjig. This can be advantageous as the stanchion can be used similarly toa sleeve to guide an implant. In an embodiment, there is at least onestanchion between a support plate 105 of an implant jig and theinterface plate 210 on a neurocap. In a further embodiment, thestanchion has at least one blind port 165 for receiving the proximal end5 of an implant. In a still further embodiment, the depth of a blindport corresponds to the depth to which an implant can be inserted intothe volume to reach a corresponding target tissue area 25.

In an embodiment, a neurocap 200 has a wall 270 that surrounds the oneor more ports. The wall can rise from the interface plate to asufficient height to form an interior 274 in which ports and/or sleeves,and the exposed ends of the implants, can be located. In a furtherembodiment, a protective cap 400 can be removably attached to or overthe wall to cover the interior and further protect the ports and/orsleeves and exposed ends. To ensure that the cap remains in place, aconnector can be used to removably connect the protective cap to thewall. The use of fitted caps and other types of caps are well-known. Byway of example, FIGS. 1, 3, 6, and 7 illustrate a wall having a shoulderindent 275 with a lip 276 over which a protective cap can be fitted. Byway of further example, the cap can be formed with an opening wideenough to fit over the wall. In a further embodiment, the indentationand the cap have matching bores 227 through which a connector can beused to removably connect the protective cap to the indentation. Thiscan inhibit the protective cap from being accidentally knocked off orremoved. A person with skill in the art will be able to determinealternative embodiments for caps or covers, including those which canresist being removed unintentionally.

Typically, when determining where to place implants, one or morelandmarks on the operating area 20 or around the operating area are usedfor orientation. For example, the bregma and lambda suture lines presenton the skulls of most animals, including humans, can be used to orientthe underlying brain tissue and locations therein. A neurocap can alsobe positioned within or on an operating area utilizing landmarks. Theneurocap can be placed on the operating area and oriented to theappropriate landmarks and marks can be made to later indicate where toplace the neurocap after implants are positioned therein. In anembodiment, alignment holes 225 in a neurocap are used to visually alignthe neurocap to natural landmarks. For example, a neurocap can have oneor more alignment holes that can be visually aligned with the bregmanand lambda sutures on a skull.

A stencil 300 could also be used to determine where a neurocap 200 canbe placed on the operating area 20. A stencil can have various sizes andtypes of openings 305 through which marks can be made on the surface ofan operating area. The marks can indicate where holes need to be made inthe operating area for different purposes. For example, marks can bemade to indicate where holes for the attachment of connectors, forexample, screws, need to be made to secure the neurocap in the operatingarea. Marks can also indicate where holes can be made for the passage ofimplants through the surface of the operating area, after a neurocap isattached. In an embodiment, the openings 305 allow for different markshapes to be made, for later identification after the stencil isremoved. For example, FIG. 9 illustrates a stencil with cross-hairopenings that can be aligned with the bregma and lambda landmarks on askull. Marks made with these openings can indicate where openings forconnectors can be made later. In an embodiment, certain of the openings305 correspond to the positions of other structures on components of astereotactic system. By way of non-limiting example, the alignment holes225 on a neurocap that can be used to fit onto alignment posts 150 on animplant jig 100 can also correspond to locations where connectors can beused to secure the neurocap to an operating surface. A stencil caninclude alignment openings that correspond to the alignment holes. FIGS.3, 8, and 9 illustrate examples of stencils that can be used withembodiments of the subject invention.

Because the alignment and position of a stencil on an operating area 20can later determine where a neurocap will be connected and how implantswill be placed in a target tissue area, accuracy of a stencil isimportant. Thus, it can be advisable for the stencil to sit on orcontact the operating area similarly to the way the neurocap will makecontact with the operating area. As discussed above, the neurocap canhave a second interface surface 220 that contacts and is attached to theoperating area. In an embodiment, the stencil has a third interfacesurface 320 on the proximal side 5 that is sufficiently similar oridentical to the second interface surface 220 on a neurocap. Thissimilarity in interfaces can allow the neurocap to contact the operatingarea the same way that the stencil does, which can improve the overallaccuracy of the neurocap and the implants used therewith. FIGS. 6 and 8illustrate a non-limiting example of second interface surface 220 havingprotrusions 222 that, while not identical, correspond to the contours ofa third interface surface 320 of a stencil.

A stencil 300 and a neurocap 200 can also have other areas that are inconformity with each other. In an embodiment, the stencil has aperipheral shaped edge 310 that corresponds to the outside edge 230 ofan interface plate 210, which is illustrated by way of example in FIGS.7 and 9. In a further embodiment, the shaped edge 310 of a stencil alsocorresponds to the edge 130 of an implant jig. A non-limiting example ofthis can be seen by comparing FIGS. 5 and 9, which show an implant jighaving an edge 130 similar to the shaped edge 310 of the stencil. Thus,there can be consistency in the edge shapes, as well as the interfacesurfaces of components of a stereotactic system, which can allcorrespond to the operating area 20.

A stereotactic system according to embodiments of the subject inventioncan be generally configured to model an organ, tissue, or structure of aspecific species. Thus, certain components of a stereotactic system 50can be consistent in shape, configuration, placement, thickness, etc. ofphysiological details of a specific species. For example, the locationof a wall 270 of a neurocap can be standard or consistent betweenstereotactic systems. Likewise, the placement of support posts 110 andstanchions 160 and margin plates 115 of an implant jig can be consistentbetween stereotactic systems. However, other components can becustomized to model the physiological characteristics of an individualwithin a specific species. For example, while the position of a marginplate can be consistent, the various interface surfaces of astereotactic system can be customized to model or closely model anoperating area of an individual subject for study or treatment.

The ability to customize components of a stereotactic system 50 candepend upon the method of manufacturing the components. It can beadvantageous if the manufacturing process can integrate detailspertaining to the operating area, such as scans, images, photographs,tactile molds, pin molds, or haptic feedback data, radiographs, andother image or shape details obtained from various devices. In anembodiment, a scanned image of the surface of an operating area, such ason a skull, can be utilized with a 3-dimensional (3D) printingapparatus. Other techniques can also be used to import or incorporatecustomization data for use in 3D printing methods. For example, pinplates can be used to mold the surface of an operating area and theinformation from each pin can be input into the 3D printing apparatus.The 3D printing apparatus can have a template for printing certainstandard, non-customized parts or areas of the system, like walls, caps,lip, support posts, but can incorporate and utilize data regarding theoperating area to customize other components, like interface surfaces,ports for implants, positioning of margin plates.

Embodiments of the subject invention provide a stereotactic system thatcan be customized to a specific species or even to individuals within aspecific species. The stereotactic system design allows forcustomization of only those specific components necessary to achieve thedesired accuracy. This can provide accuracy in implant placement.Because certain components can model specific operating areas and theunderlying tissue and organs in which a target tissue is located, it canalso allow for pre-planning of implant placement. Once implant placementis determined, components can be moved from the system to the individualfor placement and accurate insertion of the implants in the pre-plannedlocations.

Any reference in this specification to “an embodiment,” “an embodiment,”“example embodiment,” “further embodiment,” “alternative embodiment,”etc., is for literary convenience. The implication is that anyparticular feature, structure, or characteristic described in connectionwith such an embodiment is included in at least an embodiment of theinvention. The appearance of such phrases in various places in thespecification does not necessarily refer to the same embodiment. Inaddition, any elements or limitations of any invention or embodimentthereof disclosed herein can be combined with any and/or all otherelements or limitations (individually or in any combination) or anyother invention or embodiment thereof disclosed herein, and all suchcombinations are contemplated with the scope of the invention withoutlimitation thereto.

It should be understood that the examples and embodiments describedherein are for illustrative purposes only and that various modificationsor changes in light thereof will be suggested to persons skilled in theart and are to be included within the spirit and purview of thisapplication.

All patents, patent applications, provisional applications, andpublications referred to or cited herein (including those in the“References” section, if present) are incorporated by reference in theirentirety, including all figures and tables, to the extent they are notinconsistent with the explicit teachings of this specification.

What is claimed is:
 1. A method for inserting an implant into the brainof a specific species, the method comprising: obtaining at least oneimage of an operating area on a skull of a subject of the specificspecies; obtaining at least one image of a tissue corresponding to theoperating area for receiving at least one implant; customizing astereotactic system, which is adapted for placing implants in thespecific species, the system comprising: an implant jig comprising: asupport plate; at least one post extending from the support plate; andone or more margin plates affixed to the at least one post, each marginplate comprising a proximal side, a distal side, and a first interfacesurface on a distal side, the first interface surface at least partiallymodeling at least one first physiological characteristic of theoperating area of the specific species and the margin plate beingaffixed to the at least one post in a location that models at least onesecond physiological characteristic of the specific species differentfrom the first physiological characteristic; a neurocap, adapted to beaffixed to the operating area of the specific species and comprising: aninterface plate with a proximal side having a second interface surfacethat at least partially models the same at least one physiologicalcharacteristic of an operating area as that modeled by the firstinterface surface of the one or more margin plates, such that the secondinterface surface couples with the first interface surface; at least oneport that corresponds with a location in the operating area at which animplant is to be inserted into the specific species; and at least onebore that corresponds with a location in the operating area at which aconnector attaches the neurocap to the operating area; and a stencil,adapted to be temporarily placed against the operating area of thespecific species, comprising a proximal side with a third interfacesurface that at least partially models the same at least one firstphysiological characteristic as the second interface surface, thecustomizing of the stereotactic system comprising utilizing the at leastone image of the operating area to customize the placement of the atleast one port and to customize at least one of the first interfacesurface, the second interface surface, and the third interface surfaceto have at least one third physiological characteristic corresponding tothe at least one first physiological characteristic of the operatingarea, and utilizing the at least one image of the tissue to furthercustomize the at least one port and to customize a volume of the implantjig to be the same or similar to that of at least one fourthphysiological characteristic of the tissue to receive the at least oneimplant; utilizing the stencil of the stereotactic system to align withone or more landmarks on the skull and mark points for attachment of theneurocap and other points for the insertion of the at least one implantthrough the operating area; utilizing the neurocap and implant jig topre-determine the placement of the at least one implant through the atleast one port in the neurocap into the volume of the implant jig;recording a position of the at least one implant and retracting the atleast one implant into the neurocap; creating one or more burr holes inthe operating area at the points marked using the stencil; removing theneurocap from the implant jig and affixing the neurocap to the operatingarea using at least one of the burr holes; and inserting the at leastone implant into the tissue through the at least one port and the atleast one burr hole utilizing the recorded position.
 2. The methodaccording to claim 1, further comprising permanently affixing an exposedend of the at least one implant in the at least one port such that theposition of the at least one implant in the tissue is secured.
 3. Themethod according to claim 2, further comprising utilizing an adhesive tofurther attach the neurocap and to affix the exposed end of the at leastone implant in the neurocap.
 4. The method according to claim 2, whereincustomizing the first interface surface comprises making a positive moldof an operating surface on the first interface surface, and whereincustomizing the second interface surface and the third interface surfacecomprises making a negative mold of the operating surface on the secondinterface surface and the third interface surface.
 5. The methodaccording to claim 2, further comprising affixing a protective cap tothe neurocap to cover the exposed end of the at least one implant.